Clinical Trials at ChinaBio - CT (China Time, GMT+08:00)
China has become a core contributor to global clinical development. As trials move deeper into Phase II/III and global pathways, delivery quality (not volume) increasingly defines speed, credibility, and value. This opening keynote sets the context for the day by examining what has changed, why China is now a strategic choice for trials, and what “good” looks like today.
- What has fundamentally changed in China's clinical delivery over the past five years?
- Why is China now central, not supplementary, to global development strategies?
- What delivery capabilities differentiate leading programmes today?
Regulatory evolution and protocol design are now deeply interconnected. This session explores how teams design China-ready protocols that meet NMPA expectations while supporting global programmes and future scalability.
- What defines a China-ready protocol in today’s regulatory environment?
- How early should global requirements shape China trial design?
- Where do protocol decisions most affect timelines and feasibility?
China has demonstrated growing capability in Phase II and III trials. This session focuses on how experienced teams structure operations, sites and oversight to deliver large, complex studies efficiently and reliably.
- What makes China particularly well suited to late-stage trials?
- How are scale and quality managed together in practice?
- What lessons from recent Phase III programmes should others adopt?
China’s patient access remains one of its strongest advantages. This session examines how high-performing programmes translate access into consistent recruitment and retention across diverse sites and regions.
- How do successful teams translate patient access into reliable recruitment?
- Which site-level practices most improve enrolment and retention?
- How can sponsors intervene early to maintain momentum?
Chinese CROs are now integral to global drug development, offering mature quality systems, specialist capabilities, and meaningful advantages in speed and cost. At the same time, sponsors face real decisions around governance, oversight, and fit as programmes become more complex and global facing. This session cuts through assumptions to explore how experienced teams select, qualify, and work with Chinese and international CROs, and how the right partnership model can accelerate delivery while maintaining global confidence.
- What criteria should matter most when selecting a CRO for China today, and which concerns are often overstated?
- When does a Chinese CRO offer clear advantages, and when does a global CRO model make more sense?
- How can sponsors structure governance and oversight to ensure quality, speed, and regulatory confidence?
As China data increasingly supports global submissions, confidence in data quality and traceability is critical. This session explores how teams manage data processes to ensure consistency, inspection readiness and global credibility.
- What operational practices most strengthen data quality in China trials?
- How can inspection readiness be embedded early in study delivery?
- What builds global confidence in China-generated data?
AI is gaining traction across the clinical development life cycle, with the highest near‑term potential in data analysis, centralisation, monitoring and collection. Stakeholders’ expectations range from revolutionary to incremental impact, while observed benefits include shortened development timelines, improved probability of success, and more efficient trial operations through optimised design and adaptive strategies.
- Which clinical functions should be prioritised for AI deployment over the next five years?
- How can sponsors quantify AI’s impact on cycle time and PoS to guide investment?
- What governance and quality frameworks ensure reliable AI use in trial design and monitoring?